Insulin control therapy in various forms is well known. Its primary use has been relative to treatment of type 2 diabetes. Type 2 diabetes is a common disorder characterized typically by several metabolic abnormalities, including insulin resistance and insulin deficiency. These abnormalities result in hyperglycemia, which can in turn result in cardiovascular morbidity and mortality. Glucose control will delay the onset and retard the progression of microvascular and possibly macrovascular disease in those individuals having type 2 diabetes.
Various techniques and treatments are known for glucose control. In one type of treatment, lifestyle changes are used to improve insulin sensitivity. These changes include weight loss, dietary change and exercise. As the disease progresses oral insulin secretagogues and insulin sensitizers are used, either separately or together, in order to maintain proper glucose levels. In the final stages of the disease, due to its progressive nature, including the progressive decline in pancreatic beta-cell function, insulin supplementation is usually required to achieve the desired glycemic goals. This treatment requires highly motivated patients. Many individuals with type 2 diabetes, however, cannot use insulin supplementation, including the elderly and those with co-morbid conditions. For these individuals, as well as other individuals with particular medical or physical limitations, insulin administration treatments are precluded.
For certain individuals, insulin is used along with oral antidiabetic medications to normalize glycemia. This has been an effective alternative to direct injection of insulin. This type of therapy is often effective for those individuals who show some responsiveness to oral anti-diabetic medications, but where those medications are not effective by themselves. This type of therapy, however, often results in the disadvantages of weight gain and hypoglycemia.
Other treatment alternatives include the use of continuous subcutaneous insulin infusion, and intraperitoneal systems. Still other treatment regimens include inhalation and buccal insulin preparations. However, all of the above therapies have disadvantages. The medications, for instance, which force the pancreas to make still more insulin have the risk of accelerating breakdown of the entire insulin regulatory system. Other side effects are of varying severity.
Hence, it would be desirable to have an insulin control treatment that is effective for a wide range of patients, yet have few or no side effects.